Recall Monitor
Health Products

Achieva 3.0T MRI System-Main Unit

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - Radiology
Product: Achieva 3.0T MRI System-Main Unit
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
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Products

Affected productsLot or serial numberModel or catalogue number
Achieva 3.0T MRI System-Main UnitNot applicable.ACHIEVA 3.0T

Issue

Philips has become aware through in-house testing of a potential safety issue affecting MR systems operating on software versions R11.1 to R12.1 that could pose a risk for patients. Philips has identified potential stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).

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